Laboratory tests to assess sleep disorder * Diagnostic workup for the primary or co-morbid condition causing sleep disturbance * Laboratory tests for the diagnosis and monitoring of sleep disorders * Overnight polysomnography (PSG) * Multiple sleep latency tests (MSLT) * Maintenance of wakefulness test
* Actigraphy * Video-PSG * Standard electroencephalography (EEG) and video-EEG monitoring for suspected seizure disorders * Imaging studies * Upper airway imaging for obstructive sleep apnoea syndrome * Neuroimaging studies (e.
The primary endpoint of the trial is the reduction of excessive daytime sleepiness using the objective measure Maintenance of Wakefulness Test
as well as investigator assessments of narcolepsy symptoms using the Clinical Global Impressions of Change measure.
A Phase III(b) controlled clinical trial assessing the long-term efficacy of Xyrem for treating excessive daytime sleepiness (EDS) using the Epworth Sleepiness Scale and Maintenance of Wakefulness Test
will also begin in the second quarter.
Primary endpoint measures were the Maintenance of Wakefulness Test
(MWT) and the Clinical Global Impression of Change (CGI-C).
The primary end points were sleep latency (the time from lights out to sleep onset) during the Maintenance of Wakefulness Test
(a daytime sleep laboratory test) and daily sleep episodes recorded in the patient dairy.
Subjects treated with PROVIGIL experienced a statistically significant greater ability to remain awake as measured by the Maintenance of Wakefulness Test
(MWT), an objective test of a person's ability to stay awake over time, and a statistically significant improvement in disease symptom severity as measured by the Clinical Global Impression of Change (CGI-C) Scale, an independent researcher's assessment of changes in the severity of a patient's illness from the time of study entry.
Nasdaq: CEPH) announced today that a review of data from the first of two Phase II clinical trials of Provigil(TM) (modafinil) in patients with narcolepsy demonstrated that Provigil had a highly statistically significant benefit in reducing excessive daytime sleepiness as measured by the maintenance of wakefulness test
(MWT) and a physician-perceived measure of benefit to the patient (CGI-C), the two primary endpoints of the study.
Patients on both doses of armodafinil showed significantly improved daytime wakefulness, compared with placebo patients, as measured with the Maintenance of Wakefulness Test
at weeks 4, 8, and 12.
Thorpy used the Maintenance of Wakefulness Test
(MWT) as an objective measure of excessive daytime sleepiness, and the Epworth Sleepiness Scale (ESS) for a subjective assessment.